- Determine time to disease progression and progression-free interval in patients treated with this vaccine.

- Determine overall survival of patients treated with this vaccine.

OUTLINE: This is an open-label, nonrandomized study. Patients are sequentially assigned to receive dendritic cells (DC) transfected at either immature or mature stage.

Approximately 2-3 weeks before leukapheresis, patients undergo surgical excision or biopsy of the tumor to obtain tumor tissue for RNA isolation. RNA is amplified from the tumor sample by polymerase chain reaction (PCR). Patients then undergo leukapheresis to harvest peripheral blood mononuclear cells for the production of DC on day -14 . DC at immature or mature stage are transfected with autologous PCR-amplified tumor RNA to produce the vaccine. Patients receive vaccine intradermally (ID) on days 1, 15, 29, 43, 57, and between days 71-74 in the absence of disease progression or unacceptable toxicity. Patients undergo evaluation between days 71-74. Patients with responding or stable disease or minor disease progression receive booster vaccine ID on days 99, 127, between days 162-164, on day 205, between days 253-255, 351-354, 442-444, 533-535, 624-626, and 715-718 in the absence of disease progression or unacceptable toxicity. Patients also undergo additional leukapheresis between days 71-74, 351-354, and 715-718. Patients with responding or stable disease may continue to undergo leukapheresis and receive booster vaccine ID every 12-24 weeks off study.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed cutaneous melanoma*

- Stage IV disease (i.e., distant metastasis)

- Not curable by surgical resection

- NOTE: *Metastatic melanoma with an unknown primary tumor allowed provided ocular melanoma can be definitely excluded and origin from the skin is likely

NOTE: **Major surgery not allowed for the acquisition of metastatic material solely for RNA isolation

- No active CNS metastases by CT scan or MRI

- Previously treated CNS metastases (e.g., by excision of a single metastasis, gamma knife radiosurgery, or stereotactic radiotherapy) allowed provided there is no evidence of active CNS metastasis by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- Karnofsky 60-100%

Life expectancy

- At least 4 months

Hematopoietic

- WBC > 2,500/mm^3

- Neutrophil count > 1,000/mm^3

- Lymphocyte count > 700/mm^3

- Platelet count > 75,000/mm^3

- Hemoglobin > 9 g/dL

- No bleeding disorders

Hepatic

- Bilirubin < 2.0 mg/dL

- Hepatitis B surface antigen negative

- Hepatitis C antibody negative

Renal

- Creatinine < 2.5 mg/dL

Cardiovascular

- No clinically significant heart disease

Pulmonary

- No respiratory disease

Immunologic

- HIV-1 or -2 negative

- Human T-cell lymphotropic virus type I negative

- No known hypersensitivity to dimethylsulfoxide

- No immunodeficiency disease

- No active systemic infection

- No active autoimmune disease (except vitiligo), including any of the following:

- Fertile female patients must use effective contraception during and for ≥ 4 weeks after completion of study treatment

- Willing to undergo excision or biopsy of metastasis

- Willing to be hospitalized for ≥ 24 hours after each vaccination

- Medical condition stable

- No contraindication to leukapheresis

- No organic brain syndrome

- No significant psychiatric abnormality that would preclude study participation

- No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

- No other major serious illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- More than 4 weeks since prior systemic immunotherapy

- No systemic immunotherapy during and for 2 weeks after completion of study treatment

Chemotherapy

- See Disease Characteristics

- More than 4 weeks since prior systemic chemotherapy

- No systemic chemotherapy during and for 2 weeks after completion of study treatment

Endocrine therapy

- No systemic corticosteroids, including steroid-containing inhalers or chronic use of topical steroids over large areas of the body (if systemic effects are likely or obvious) during and for 2 weeks after completion of study treatment

Study ID:

NCT ID:

Start Date:

Completion Date:

Related Keywords:

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